The Effects of Caffeinated Coffee on Intraocular Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in Intraocular Pressure at 60 Minutes
研究概览
简要总结
High intraocular pressure (IOP) is a known risk factor for developing primary open-angle glaucoma (POAG). There is controversy in the literature regarding the degree to which caffeine influences IOP, with some studies reporting minimal changes in IOP while others report up to 4 mmHg increases. To date there are no double-masked randomized controlled trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk for primary open-angle glaucoma. The investigators aim to better understand the relationship between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a double-masked, crossover randomized controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-89 yrs
- •POAG for cases or no forms of glaucoma for controls
- •Willingness to drink coffee
- •Consent signed
排除标准
- •Age less than 40 or greater than 89 yrs
- •all forms of glaucoma other than POAG
- •any condition inappropriate for tonometry (ie corneal disease, LASIK)
- •unable or unwilling to give consent
- •unable or unwilling to drink coffee
- •pregnancy
结局指标
主要结局
Change in Intraocular Pressure at 60 Minutes
时间窗: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion
At the caffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion At the decaffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion
Change in Intraocular Pressure at 90 Minutes
时间窗: Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion
At the caffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion At the decaffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion
次要结局
未报告次要终点